Tongue-strengthening Exercises in People With ALS.

NCT ID: NCT07295990

Last Updated: 2025-12-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief Summary

This study is testing a tongue exercise program for people living with ALS to see if it can help support speech and swallowing. All participants will receive the treatment, and researchers will measure changes over time by comparing each person's results to their own earlier results.

People who join the study will have two in-person visits, one virtual visit, and four weekly telehealth sessions with a speech-language pathologist. During these sessions, participants will practice tongue resistance exercises, complete speech and swallowing tasks, and answer surveys about their experience. They will also use a small device at home to measure tongue strength and swallowing.

The exercise program involves pressing the tongue against a device several times a day, five days per week, for five weeks. Researchers want to learn if this program is safe, practical, and helpful for people with ALS.

Detailed Description

Study Description

Brief Summary:

This study is designed to evaluate the effects of isometric lingual strengthening exercises on speech and swallowing function in individuals with Amyotrophic Lateral Sclerosis (ALS). By targeting tongue strength, we aim to improve pressure generation, support safer and more efficient swallowing, enhance speech intelligibility, and examine the relationship between lingual strength and patient-reported outcomes.

Detailed Description:

Amyotrophic Lateral Sclerosis (ALS) often results in progressive weakness of the tongue and other oral structures, which contributes to impaired speech intelligibility, swallowing safety, and overall quality of life. Lingual strengthening exercises may offer a non-invasive, behavioral intervention to preserve oral function in this population. However, the efficacy and broader impact of such exercises remain underexplored.

The aims of this study are to:

Evaluate the efficacy of isometric lingual strength exercises in improving tongue pressure generation in people with ALS (pALS).

Investigate the impact of lingual strengthening exercises on speech intelligibility, swallowing safety, and swallowing efficiency.

Assess the relationship between lingual strength, speech intelligibility, swallowing function, and patient-reported outcomes related to motor speech, swallowing-related quality of life, and fatigue.

Methods and Study Design:

This study uses a delayed-start, repeated-measures design in which participants serve as their own controls. This approach allows all participants to receive the intervention while also accounting for disease heterogeneity and interparticipant variability.

Participants will complete two baseline assessments (in-person at Week 0, virtual at Week 5), a 5-week intervention phase (Weeks 5-10), and a final in-person evaluation at Week 10. A follow-up strength assessment will occur at the participant's next scheduled multidisciplinary ALS Clinic visit (~6 months).

Study Procedures and Timeline:

Screening / Baseline 1 (Week 0, in-person, 60-90 min):

Informed consent and eligibility screening.

Assessments: Maximum isometric lingual pressure (Tongueometer), 3D tongue ultrasound, Bamboo Passage (speech rate), oral diadochokinesis (temporal variability), 3-ounce water test (swallowing safety), TOMASS (oral efficiency), videofluoroscopic swallow study (VFSS), and patient-reported measures (Eat-10, ALSFRS-R, ETBQ).

Baseline 2 (Week 5, virtual, 60-90 min):

Repeat assessments from Baseline 1, excluding VFSS and ultrasound.

Introduction of isometric lingual strength training; first training session completed during this visit.

Telehealth Training Sessions (Weeks 5-10, weekly, 30-60 min each):

Conducted via Zoom.

Tongue resistance training, Bamboo Passage, diadochokinesis, 3-ounce water test.

Patient-reported measures (ALSFRS-R, ETBQ, Eat-10).

Research clinician monitors fidelity, provides progression adjustments, and records data.

Active Exercise Training Regimen:

Frequency: 5 sessions per week for 5 weeks.

Intensity: 60% of each participant's maximum anterior lingual pressure (MAIP).

Volume: 6 sets of 5 repetitions/day (30 repetitions/day; 150 repetitions/week).

Contraction: 2-second hold for each isometric press.

Progression: Training thresholds updated weekly to maintain 60% MAIP.

Final Evaluation (Week 10, in-person):

Assessments identical to Baseline 2 with inclusion of VFSS, ultrasound, and ETBQ.

Follow-up (6 months, routine ALS clinic visit):

Isometric lingual strength assessment repeated using the Tongueometer.

Exploratory Outcome:

Ultrasound imaging will be completed at baseline and final evaluations to quantify morphologic changes in tongue structure related to exercise.

Conditions

ALS (Amyotrophic Lateral Sclerosis); ALS - Amyotrophic Lateral Sclerosis

Keywords

Dysarthria; ALS; Amyotrophic Lateral Sclerosis; Dysphagia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dysphagia Exercise Intervention

This study arm will test a proactive dysphagia exercise program using lingual manometry and isometric lingual strength training in people with ALS (pALS). The intervention is designed to maximize lingual strength, improve speech intelligibility, enhance swallow safety and efficiency, and support patient-reported swallowing and quality-of-life outcomes in individuals with minimal decline in tongue function.

Group Type: EXPERIMENTAL

Isometric Lingual Strength Exercises

Intervention Type: PROCEDURE

Direct intervention will consist of an isometric lingual exercise program designed specifically for patients with ALS. Participants will complete five exercise sessions per week for a total of five weeks, with each session including six sets of five repetitions (30 repetitions daily, 150 repetitions weekly). Exercises will be performed at 60% of each participant's maximum isometric anterior lingual pressure (MAIP), with each tongue press held for approximately two seconds. Training thresholds will be adjusted weekly via telehealth to ensure the program remains at the prescribed 60% intensity, supporting both safety and consistency in progression. This structured protocol is intended to maximize lingual strength, swallow function, and overall adherence to the intervention.

Interventions

Isometric Lingual Strength Exercises

Direct intervention will consist of an isometric lingual exercise program designed specifically for patients with ALS. Participants will complete five exercise sessions per week for a total of five weeks, with each session including six sets of five repetitions (30 repetitions daily, 150 repetitions weekly). Exercises will be performed at 60% of each participant's maximum isometric anterior lingual pressure (MAIP), with each tongue press held for approximately two seconds. Training thresholds will be adjusted weekly via telehealth to ensure the program remains at the prescribed 60% intensity, supporting both safety and consistency in progression. This structured protocol is intended to maximize lingual strength, swallow function, and overall adherence to the intervention.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of possible, probable, or definite ALS (El-Escorial Revisited)
• Lingual exercises naïve
• Impaired lingual strength generation compared to normative data (<43 kPa; Robinson et al., 2023)
• EAT-10 score <3

Exclusion Criteria

• Stroke
• Head injury
• Head and neck cancer
• Tracheostomy
• Other concomitant neurogenic disorder
• Recent oral surgery other than routine dental surgery
• Unable to generate isometric lingual pressure on lingual manometer
• Participation in another clinical trial intervention that may confound results
• NPO (nothing by mouth)
• Anarthric

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Southeastern University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Tabor Gray, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Neuroscience Institute, Cathy J. Husman ALS Center

Central Contacts

Raquel Garcia, SLP.D

Role: CONTACT

Phone: 17863994053

Email: rw602@nova.edu

Lauren Tabor Gray, Ph.D.

Role: CONTACT

Phone: 9549145447

Email: lauren.taborgray@nova.edu

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Dysphagia Exercise ALS

Identifier Type: -

Identifier Source: org_study_id